BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 2477939 · Received March 5, 2012

    Report

    Report Number
    1823260-2012-01232
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    January 31, 2012
    Report Date
    March 5, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR GLUCOSE HK (GLUCOSE). THE SERUM SAMPLE INITIALLY RESULTED AS "AROUND 371 MG/DL" AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR ORDERED AN ADD-ON HBA1C TO THE EDTA PLASMA TUBE ALREADY PRESENT IN THE LAB AND THE RESULTS WERE NORMAL. BASED ON THIS, THE DOCTOR ORDERED REPEAT GLUCOSE TESTING ON THE ORIGINAL SAMPLE. THE CUSTOMER PULLED BOTH THE PRIMARY TUBE AND AN ALIQUOT TUBE AND REPEATED THESE. BOTH RESULTED IN THE "80S" MG/DL. THE CUSTOMER CONSIDERED THE REPEAT RESULT TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE GLUCOSE REAGENT LOTS AND EXPIRATION DATES WERE NOT PROVIDED BY THE CUSTOMER. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROL; ALL RESULTS WERE WITHIN CUSTOMER SPECIFICATIONS. THE FIELD SERVICE REPRESENTATIVE RAN A PRECISION AND THIS PASSED. A ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER REFUSED TO PROVIDE FURTHER INFORMATION. NO PROBLEM IS INDICATED WITH THE INSTRUMENT OR REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER CFR ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1